Events

Safety Alert for INSTRUMENTATION MACHINERY FOR MEDTRONIC LOADING. Anvisa Registers n ° 10339190361 (Medtronic Comercial Ltda) and n ° 10099430171 (Dabasons Importação Exportação e Comércio Ltda).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA e DABASONS IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO LTDA.; MEDTRONIC NAVIGATION INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1637
  • Date
    2015-07-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Cannulated macheters are surgically used to prepare the anatomy of the spine for screw placement. They can be used with guide wires to aid placement. If they are not used with guidewires, the bone material may accumulate in the lumen of these devices. If cleaning the macheter is not done properly and in accordance with the instructions in force for cleaning, the bone material will harden, causing difficulties in subsequent cleaning. If the cleaner uses a sharp instrument in an attempt to remove buildup of bone tissue, injury may occur if no precaution is taken. It is recommended to use the guidewire during the surgical procedure and to be careful when cleaning the macheadores if sharp instruments are used. If the obstruction in the cannula can not be removed, the instructions for use indicate that the devices should be considered at the end of their useful life and should be discarded according to the installation procedures and guidelines. A copy of the updated instructions for use will be sent to the customer, as informed by Medtronic Comercial Ltda. This field action involves two distinct registers, but it is the same product. The field action will be carried out by Medtronic Comercial Ltda.
  • Reason
    Use of the mats without the guidewire can lead to an accumulation of bone or other tissues in your cannula, which can result in injury to users of the product when cleaning the device.
  • Action
    Changing the directions for use of the product to clearly detail the potential for bone / tissue accumulation in the product cannula (especially if used without the guidewire) and warn the user of the risk of injury while cleaning the device.

Device

INSTRUMENTATION MACHINERY FOR MEDTRONIC LOADING. Anvisa Registers n ° 10339190361 (Medtronic Come...

Manufacturer

MEDTRONIC COMERCIAL LTDA e DABASONS IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO LTDA.; MEDTRONIC NAVIGATION INC
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA